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RECRUITING
NCT06378437
PHASE1

A Study of GLB-001 in Patients With Myeloid Malignancies

Sponsor: Hangzhou GluBio Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

Study GLB-001-02 is a phase 1, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-001 in study participants with relapsed or refractory or intolerant myeloid malignancies including polycythemia vera (PV), essential thrombocythemia (ET), myelofibrosis (MF), lower-risk myelodysplastic syndrome (LR-MDS), higher-risk myelodysplastic syndromes (HR-MDS), and acute myeloid leukemia (AML). This study consists of 3 parts, dose escalation (Phase 1a), dose exploration (Phase 1b) and dose expansion (Phase 1c). Dose escalation (Phase 1a) and dose exploration (Phase 1b) will evaluate the safety, tolerability, PK, PD and preliminary efficacy of GLB-001, administered orally, in study participants with PV/ET, or study participants with MF/LR-MDS/HR-MDS/AML, respectively. Dose expansion (Phase 1c) will be followed to determine the relationships among dose, exposure, toxicity, tolerability and clinical activity, to identify minimally active dose, and to select the recommended dose(s) for phase 2 study. Approximately 108 study participants may be enrolled in the study.

Official title: A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of GLB-001 in Patients With Myeloid Malignancies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2024-05-24

Completion Date

2027-12-31

Last Updated

2025-08-19

Healthy Volunteers

No

Interventions

DRUG

GLB-001

Administered orally according to the assigned treatment schedule

Locations (14)

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

Hefei, Anhui, China

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The First Hospital of Hebei Medical Universtiy

Shijiazhuang, Hebei, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Sheng Jing Hospital of China Medical Universtiy

Shenyang, Liaoning, China

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

The Second Hospital of Tianjin Medical Universtiy

Tianjin, Tianjin Municipality, China

The First Affilicated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China